Depomed Reports Positive Efficacy Data From a Phase 2 Trial of
Gabapentin GR in the Treatment of Menopausal Hot Flashes

MENLO PARK, Calif.--(BUSINESS WIRE)--Feb. 12, 2008 - Depomed, Inc.
(NASDAQ:DEPO) today announced positive efficacy results from a
Phase 2 double-blind, placebo-controlled, multi-center trial
evaluating Gabapentin GR(TM) for the treatment of women with
moderate-to-severe menopausal hot flashes. The 124 patient study
showed that Gabapentin GR, an extended release formulation of
gabapentin developed using Depomed's AcuForm(TM) drug delivery
technology, significantly reduced the frequency and severity of hot
flashes from baseline to the end of treatment compared to placebo.
A decrease of at least 80% in the frequency of moderate to severe
hot flashes was observed in 63% of patients in the 1800mg treatment
arm, compared to 20% of placebo patients, which decrease was
statistically significant (p less than 0.001). Gabapentin GR was
well tolerated in the study.

"We are very pleased with the performance of our product. It
delivered clinically meaningful and statistically significant
efficacy in the management of menopausal hot flashes and exhibited
a good tolerability profile. The results should prove invaluable as
we begin planning the design of our Phase 3 program, and will
provide important insight to potential partners evaluating this
opportunity," said Carl A. Pelzel, president and chief executive
officer of Depomed. "We are excited to move this important program
forward as it addresses an area of high unmet medical need,
especially as concerns over the use of estrogen become more acute
and as doubts deepen regarding the value of herbal remedies that
are being used. The next step in our program will be to discuss the
results of this study with the FDA during an end of Phase 2 meeting
later this year."

Study Design

The study included 124 menopausal women (approximately 30 per
group) with recurrent, moderate to severe hot flashes and was
conducted at eight sites in the United States. The total study
treatment duration after screening and baseline was 13 weeks. The
primary objective of the study was to investigate the relationship
between blood plasma concentrations of gabapentin observed in
menopausal women after administration of Gabapentin GR and the
frequency of hot flashes in those women. The plasma concentration
data (pharmacokinetics) and the hot flash frequency and severity
data (pharmacodynamics) will be used to contsruct a PK/PD dose
response model designed to identify the dosing regimen to utilize
in a Phase 3 program. The dose response model is expected to be
presented to the FDA at an end of Phase 2 meeting later this
year.

In order to facilitate the generation of an optimal dose
response model, patients in each of the three active treatment arms
remained on a stable Gabapentin GR dose for five weeks at an
initial dose (600mg once daily; 1200mg in divided 600mg doses; or
1200mg once daily), followed by five weeks on a stable,
incrementally higher dose (1800mg in divided 600mg and 1200mg
doses; 2400mg in divided 600 and 1800mg doses; and 3000mg in
divided 1200mg and 1800mg doses). Each stable dosing regimen was
preceded by a one-week titration period.

Commenting on the study design, Dr. Carl Peck, former head of
FDA's CDER (Center for Drug Evaluation and Research) and Chairman
of NDA Partners LLC, said "The FDA should really like this
learning/confirming trial, which fits well with FDA's Critical Path
Initiative on model-based drug development. This is a 'best in
class', randomized, blinded, exposure-response evaluation of
gabapentin's ability to decrease hot flashes that will both inform
the pivotal Phase 3 trial design and may serve as independent
evidence of effectiveness and safety." Dr. Peck consults for
Depomed.

Efficacy Outcomes

Gabapentin GR demonstrated a reduction in the frequency of
moderate to severe hot flashes, and in the severity of hot flashes,
in all active treatment groups, with statistical significance
relative to placebo from baseline to the end of the study observed
in the 1800mg and 2400mg treatment groups. In the 1800mg treatment
group, the mean number of moderate to severe hot flashes was
reduced from 10.1 at baseline to 2.7 at endpoint (p=0.016), with
similar results in the 2400mg treatment groups, compared to an
endpoint value of 5.1 for the placebo group.

Safety

Gabapentin GR was well tolerated in the study, with one, two,
one and three patients, respectively, withdrawing due to adverse
events from the placebo, 1800mg, 2400mg and 3000mg groups. The most
common side effects observed in the study were headache, somnolence
and dizziness.

Webcast

The results of this study will be presented today, Tuesday, Feb.
12, 2008 at 11 AM ET by Carl A. Pelzel, president and CEO of
Depomed, during the 10th Annual BIO CEO & Investor Conference
to be held in New York, NY. Interested parties can access a live,
or archived, webcast of the presentation on the company's website
at www.depomed.com.

About Gabapentin GR

Gabapentin GR is an investigational, extended release
formulation of gabapentin, an FDA-approved drug for the treatment
of seizures and postherpetic neuralgia. Published data on the use
of gabapentin in menopausal women provide investigational support
for the efficacy of the compound to address hot flash symptoms. A
study published in the July 2006 issue of Obstetrics &
Gynecology reported that gabapentin appeared to be as effective as
estrogen in treating hot flashes. Recent studies have suggested a
link between hormone replacement therapy and breast cancer. In the
Position Statement of the North American Menopause Society (NAMS)
regarding treatment of menopause-associated vasomotor symptoms
(2004), gabapentin is reviewed as a recommended nonhormonal
option.

Formulated with Depomed's proprietary AcuForm drug delivery
technology, Gabapentin GR holds the potential to offer women
experiencing menopausal hot flashes the relief provided by hormone
replacement therapy without the exposure to hormones, and with
fewer side effects and a more convenient dosing regimen. The
company has sublicensed the exclusive right to develop and
commercialize gabapentin for the treatment of menopausal hot
flashes under a U.S. patent held by the University of Rochester
covering the use of gabapentin for the treatment of menopausal hot
flashes.

About Hot Flashes

Approximately 80 percent of women in the United States have hot
flashes at some level of intensity during perimenopause. Hot
flashes, also known as vasomotor symptoms, are sudden waves of heat
that can start in the waist or chest and work their way to the neck
and face and sometimes over the rest of the body. Hot flashes are
characterized by a sudden temporary onset of body warmth, flushing
and sweating. Depending on the intensity of the hot flash, some
women may experience headaches, fatigue, dizziness, or heart
palpitations. The only government-approved single agent therapy in
both the United States and Canada for treating this
menopause-related symptom is prescription estrogen, which has been
associated with increased risk of breast cancer, coronary heart
disease, thromboembolism, stroke and dementia.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company with two
approved products on the market and other product candidates in its
pipeline. The company utilizes its proven, proprietary AcuForm(TM)
drug delivery technology to improve existing oral medications,
allowing for extended, controlled release of medications to the
upper gastrointestinal tract. Benefits of AcuForm-enhanced
pharmaceuticals include the convenience of once-daily
administration, improved treatment tolerability and enhanced
compliance and efficacy. Glumetza(R) (metformin hydrochloride
extended release tablets) is approved for use in adults with type 2
diabetes. Proquin(R) XR (ciprofloxacin hydrochloride) extended
release tablets are approved in the United States for the
once-daily treatment of uncomplicated urinary tract infections and
will be marketed in the United States within the urology specialty
by Watson Pharmaceuticals. Product candidate Gabapentin GR(TM) is
currently in clinical development for the treatment of neuropathic
pain and for menopausal hot flashes. Additional information about
Depomed may be found on its web site, www.depomed.com.

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